Tuesday, 11 August 2015

ISO 14644 ballot delay

As
regular readers of this website – PharmaceuticalMicrobiology – will be aware, the main international cleanroom standard is
at final draft stage for parts 1 and 2. With this comes the proposal to change
the way that the particle count classification of cleanrooms is undertaken.
This includes the introduction of a ‘look-up table’ for particle count
locations; and new approach to sample volumes; and key guidance for in-process
monitoring.

The
provisional implementation date was mooted to be September 2015. ISO have now indicated that final ballots on
FDIS 14644-1 and FDIS 14644-2 will open on 27th August 2015.

Based
on this information interested parties should not expect the revised standards
to be published until later this year or early into 2016.